Safety Study of AZD5672 in Renally Impaired Subjects
Study identifier:D1710C00020
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients with Renal Impairment and Healthy Volunteers
Medical condition
Renal Impairment
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5672
Sex
All
Actual Enrollment
40
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jul 2008
Primary Completion Date: 01 Feb 2009
Study Completion Date: 01 Feb 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Patients with Moderate renal impairment and matched volunteers | Drug: AZD5672 100 mg oral single dose |
| Experimental: 2 Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data | Drug: AZD5672 100 mg oral single dose |
Contacts
Investigators
Principal Investigator
Rod Hepburn
AstraZeneca R&D, Charnwood, UK
